Antiseptic Cap

ABSTRACT

The present invention provides an antiseptic cap for use with an access site having a housing with a wall defining a chamber, the wall having a set of threads on an inner surface of the wall; and an access site contacting surface associated with the housing having an antiseptic substance for contacting a surface of the access site. The present invention also provides an antiseptic cap equipped plunger assembly wherein an antiseptic cap is retained within a housing of the plunger.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/821,190, filed on Jun. 22, 2007, which claims the benefit of U.S.Provisional Application Ser. No. 60/815,806 filed on Jun. 22, 2006, theentire disclosures of which are all expressly incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Technical Field

The present invention relates to an antiseptic cap and an antiseptic capequipped syringe plunger assembly and more particularly to an antisepticcap for attaching to a portion of an indwelling, central venous catheterand delivering an antiseptic composition or liquid to a lumen of thecatheter.

2. Background Art

Catheters are widely used to treat patients requiring a variety ofmedical procedures. Catheters can either be acute, or temporary, forshort-term use or chronic for long-term treatment. Catheters arecommonly inserted into central veins (such as the vena cava) fromperipheral vein sites to provide access to a patient's vascular system.Catheters offer many advantages for patients; for example, chroniccatheters provide ready access without repeated punctures or repeatedvessel cannulation for administration of large volumes of fluids,nutrients and medications and for withdrawal of blood on an intermittentbasis. With respect to the use of catheters for infusion of fluids,examples include the infusion of drugs, electrolytes or fluids used inchemotherapy. In chemotherapy, catheters are used for infusion of drugson an intermittent basis, ranging from daily to weekly. Another exampleincludes the use of catheters in hyperalimentation treatment, whereinthe catheters are usually used for infusion of large volumes of fluids.

For hemodialysis, catheters are commonly used—usually three times perweek—for aspiration of blood for dialysis treatment and rapid return ofthe blood to circulation after treatment. Although a preferred mode ofvascular access for a hemodialysis patient involves using anarteriovenous (AV) fistula of either the upper or lower extremities oran arteriovenous “bridge” graft (typically utilizing PTFE), use of theseaccess devices is not always possible or desirable. When either of thesemodes of vascular access is not available, for example, due to a paucityof adequate blood vessels for creation of AV “shunts” or due tononoptimally functioning established AV shunts, a large bore venous linecatheter is typically required for hemodialysis. Catheters used forhemodialysis usually include two relatively large diameter lumens(usually molded as one catheter) for aspiration and rapid return ofblood required during the hemodialysis procedure. One lumen of such acatheter is used for aspiration, or removal, of blood, while the otherlumen is used for returning the blood to the patient's bloodstream.

Catheter connections, such as, for example, connections of catheters todialysis machine tubing, to IV line tubing, to infusion ports and tocatheter caps, which are used to seal the end of a catheter to protectthe sterility of the catheter and prevent fluid loss and/or particlecontamination, are most often made utilizing the medical industry'sstandardized Luer taper fittings. These fittings, which may either bemale couplings or female couplings, include a tapered end ofstandardized dimensions. Coupling is made by the press-fit of matingparts. A threaded lock-fit or other type of securing mechanism iscommonly utilized to ensure the integrity of the pressure fit of theLuer fittings.

Catheters, especially chronic venous catheters, provide challenges intheir use. One such challenge is that such catheters can become occludedby a thrombus. In order to prevent clotting of catheters in bloodvessels between uses, such as, for example, between dialysis treatmentswhen the catheter is essentially nonfunctioning and dwells inside a“central” vein (i.e. superior vena cava, inferior vena cava, iliac,etc.), the lumens of the catheter are often filled with a lock solutionof a concentrated solution of the commonly used anticoagulant, heparin(up to 10,000 units of heparin per catheter lumen).

As used herein, the terms “lock solution” or “locking solution” refer toa solution that is injected or otherwise infused into a lumen of acatheter with the intention of allowing a substantial portion of thelock solution to remain in the lumen and not in the systemic bloodcirculation until it is desired or required to access that particularlumen again, typically for additional treatment, i.e., infusion orwithdrawal of fluid. In addition, attention has been given to thedevelopment of alternative lock solutions with the goal of improving thepatency rates of vascular catheters. For example, lower-alcoholcontaining locking solutions are under development wherein the loweralcohols include ethanol, propanol and butanol. Anti-microbial and oranticoagulant additives can optionally be added to the lower-alcoholcontaining locking solution. Preferably the lock solution can remain inthe lumen for a desired amount of time lasting from about 1 hour to 3 or4 days or longer.

For the reasons set forth above, significant care must be taken wheninfusing medications, nutrients and the like into a catheter, and when“locking” a catheter between uses, to minimize the risks associated withan indwelling catheter, including the risk of thrombosis or clotting,the risk of excessive anticoagulating and the risk of infection.Syringes are typically used to administer the required amount ofcatheter lock solution (determined by the catheter manufacturer) into anindwelling catheter after a given use. Flush procedures also requirethat care be taken to prevent blood reflux into the catheter. Reflux inI.V. therapy is the term commonly used to describe the fluid that isdrawn back into the catheter after a flush procedure. The concern isthat the reflux fluid contains blood or solution that could cause thecatheter to occlude. To ensure that reflux does not occur, flushprocedures suggest two techniques: 1) at the end of the flush solutiondelivery, the user maintains pressure on the syringe plunger whileclamping the I.V. line; or 2) while delivering the last 0.5 ml of flushsolution disconnect the syringe from the I.V. port or clamp the I.V.line. Either technique maintains positive pressure on the fluid in thecatheter to prevent reflux of fluid and blood.

Another concern in catheter care is the prevention of infections. Oncesource of infections can be through germs that enter the blood streamfrom the open end of the catheter. Various techniques are known in theart of blocking the exit of the catheter to prevent the refluxing ofblood up the catheter and to close the system off from generalatmosphere. Certain closures are straight-forward screw-caps that fitover the luer end of the catheter. Others are complex valving systemsthat may reduce reflux during detachment of the syringes or otherconnections. Others are pre-slit septums that seal together when thesyringe or connected device is removed.

Current procedures to reduce contamination of a catheter, duringconnection and disconnection, is to swab the connection hub with adisinfectant such as an alcohol. This procedure is prone to human errorsuch as failing to allow sufficient between swabbing and closing of thecatheter. Further, sometimes the swabbing step is skipped all together.

In light of the above-described problems, there is a continuing need foradvancements in catheter lock techniques, devices and procedures toimprove the safety and efficacy of catheter locking procedures, thecleanliness and disinfection of catheter connections and of overallpatient care.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an antiseptic cap equipped plunger andsyringe barrel assembly prior to connection of a syringe tip to anaccess point to a central venous catheter;

FIG. 2 is a perspective view of an antiseptic cap equipped plunger andsyringe barrel assembly with the syringe tip connected to an accesspoint to a central venous catheter and the plunger assembly is fullydepressed within the syringe barrel;

FIG. 3 is a perspective view of an antiseptic cap equipped plunger andsyringe barrel assembly prior to connection of the antiseptic cap to anaccess point to a central venous catheter;

FIG. 4 is a perspective view of an antiseptic cap equipped plunger andsyringe barrel assembly after connection of the antiseptic cap to anaccess point to a central venous catheter;

FIG. 5 is a perspective view assembly drawing of an antiseptic capequipped plunger;

FIG. 6 is a perspective view of an antiseptic cap equipped plunger in apartially assembled state;

FIG. 7 is a perspective view of the antiseptic cap equipped plunger ofFIG. 6 with a top seal;

FIG. 8 is a perspective view of an antiseptic cap equipped plunger ofFIG. 7 mounted in a lumen of a syringe barrel;

FIG. 9 is a side view in cutaway of an antiseptic cap equipped plungerand syringe barrel assembly;

FIG. 10 shows an exploded view of a detail of FIG. 9 of one embodimentof the antiseptic cap equipped plunger and syringe barrel assemblywithout the cap inserted;

FIG. 11 shows an exploded view of a detail of FIG. 9 of anotherembodiment of the antiseptic cap equipped plunger and syringe barrelassembly with the cap inserted;

FIGS. 12-14 show various embodiments of grips of the antiseptic capequipped plunger assembly;

FIGS. 15-17 show various views of one embodiment antiseptic cap equippedplunger and syringe barrel assembly with a barrel lock to resistrotation of the plunger assembly with respect to the syringe barrel;

FIG. 18 shows another embodiment of a barrel lock to resist rotation ofthe plunger assembly with respect to the syringe barrel;

FIGS. 19-20 show various views of another embodiment antiseptic capequipped plunger and anti-reflux syringe barrel assembly with a barrellock to resist rotation of the plunger assembly with respect to thesyringe barrel;

FIG. 21 shows a perspective view of another embodiment antiseptic capequipped plunger and syringe barrel assembly with a barrel lock toresist rotation of the plunger assembly with respect to the syringebarrel;

FIGS. 22 a,b are respectively a perspective view of an antiseptic capwithout a sponge and with a sponge;

FIGS. 23 and 24 are different embodiments of the antiseptic cap withvarying gripping features;

FIG. 25 is a perspective view of the antiseptic cap of FIG. 22 b priorto docking with a valve;

FIG. 26 is a perspective view of the antiseptic cap of FIG. 22 b dockedwith a valve;

FIG. 27 is a side view in cutaway of the antiseptic cap and valveassembly shown in FIG. 26;

FIGS. 28-30 are side views in cutaway of two different embodiments ofthe antiseptic cap;

FIGS. 31 a,b are, respectively, side views in cutaway showing anantiseptic cap with a centrally disposed actuation post mounted on avalve with the valve in the unactivated and activated positions;

FIGS. 32 and 33 are side views in cutaway showing two differentembodiments of an antiseptic cap having a molded sponge;

FIG. 34 is a side view in cutaway showing another embodiment of anantiseptic cap having a molded sponge docked to a valve;

FIG. 35 is a side view in cutaway showing a step of attaching a moldedsponge to an antiseptic cap;

FIG. 36 is a side view in cutaway showing a step of delivering anantiseptic compound to a molded sponge positioned within a cap;

FIG. 37 shows a side view in cutaway of an antiseptic cap docking to avalve with the antiseptic cap having an antiseptic coating; and

FIG. 38 shows a perspective view of an antiseptic cap in a blisterpackage.

DETAILED DESCRIPTION OF THE INVENTION

While this invention is susceptible of embodiment in many differentforms, there are shown in the drawings, and will be described herein indetail, specific embodiments thereof with the understanding that thepresent disclosure is to be considered as an exemplification of theprinciples of the invention and is not intended to limit the inventionto the specific embodiments illustrated.

FIGS. 1 and 2 show an antiseptic cap equipped plunger and syringe barrelassembly 10 having an antiseptic cap equipped plunger (or piston)assembly 12 and a syringe barrel 14. The barrel 14 has a side wall 16defining a chamber 18 and the barrel has a proximal end 20 and a distalend 22. The proximal end 20 has an opening 23 to the chamber 18 and aflange 24 extending radially outwardly from the wall 16. The flange 24has upper and lower surfaces 26, 28 and provides gripping surfaces for auser of the assembly 10. The distal end 22 of the barrel 14 has an endwall 30 and an elongate tip 32 extending distally therefrom and having apassageway 34 therethrough and in fluid communication with the chamber18. The distal end wall 30, in one preferred form of the invention, isgenerally conically shaped and, as is well known in the art, can have alocking luer collar 35 concentrically surrounding the tip 32 and havinga set of threads 37 on an inside surface thereof. The luer collar 35allows for attaching a needle or a cannula to the syringe assembly andfor docking the assembly to mating threads located on other devices suchas valves and injection sites. FIG. 1 shows the syringe assemblyproximate an access site 38 having a valve 39 controlling access to alumen of a tubing 41.

In one preferred form of the invention the chamber 18 of the syringeassembly will be filled with a locking solution or a flush solution foruse with an indwelling, central venous catheter. The manner of using alocking or flush solution with a catheter is well known in the art.Suitable locking or flushing solutions will be set forth below. Theflush or locking solution is injected into a fluid access site of thecatheter to clean and disinfect the catheter and can be withdrawn fromthe catheter or allowed to remain in an end portion of the catheter toserve as a barrier to the ingress of pathogens and contaminants.

The antiseptic cap plunger assembly 12 has an elongate shaft 40, aproximal end 42 and a distal end 44. The elongate shaft 40, in onepreferred form of the invention, is generally cruciform incross-sectional shape. A stopper or piston 50 is connected to the distalend 44 of the plunger 12. The piston 50 is dimensioned such that wheninserted into the syringe barrel chamber 18 an outer circumferentialsurface of the piston is in fluid-tight engagement with an inner surface54 of the syringe barrel. The piston assembly 12 when moved proximally(or when being withdrawn) can draw fluid into the chamber and when moveddistally (or when inserted into the syringe chamber) can drive fluid outof the chamber. FIG. 1 shows the piston assembly 12 partially insertedinto the syringe chamber and FIG. 2 shows the piston assembly fullyinserted into the syringe chamber to deliver fluid to the tubing 41.

A housing 60 is located at the proximal end of the plunger assembly 12and has a wall 62 defining a chamber 64 having an open end 66 which canbe sealed by any suitable structure or material such as a cap or by afoil material 68. An optional annular flange 70 extends radiallyoutwardly from the wall 62 and provides a surface upon which the sealingstructure can be attached.

FIG. 5 shows a cap assembly 80 proximate the chamber 64 of the housing60 and FIG. 6 shows the cap assembly 80 within the chamber 64. In onepreferred form of the invention, the cap assembly 80 has a cap 82defining a chamber 84 containing an absorbent material 86 such as asponge. The sponge 86, in a preferred form of the invention, is wettedor soaked with an agent such as an antiseptic, anticoagulant orantimicrobial and can be selected from the locking and flushingsolutions set forth below. The cap 82 has an interior surface 87 with aset of threads 88 for mating with a set of threads on the access site39.

FIGS. 7 and 8 show the cap assembly 80 sealed with a foil material orlid stock material 68 which can be attached to the flange 70 by anysuitable method such as by adhesives or by conductive or inductive heatsealing techniques. FIG. 7 shows the antiseptic cap piston assembly 12and FIG. 8 shows the antiseptic cap equipped piston assembly 12 insertedinto the chamber of the syringe barrel 14 to define the antiseptic capequipped piston and syringe barrel assembly 10.

FIGS. 3 and 4 show one possible method for utilizing the cap assembly 80by docking with the valve 39. FIG. 3 shows the lid stock 68 pealed awayfrom the flange 70 and FIG. 4 shows docking the antiseptic cap to thevalve 39. The syringe barrel with be rotated clockwise orcounterclockwise to engage the threads 88 of the antiseptic cap assembly80 to the threads of the access site 38. After engagement the syringebarrel will be moved away from the access site 38 and the antiseptic cap80 will slide outward from the housing 60 and remain docked to theaccess site 39. The antiseptic cap assembly 80 can be allowed to remaindocked to the valve 39 for any suitable period of time from a fewminutes to numerous hours. When the antiseptic cap assembly 80 is dockedto the valve 39 the tubing or catheter 41 is sealed to block the ingressinto the catheter of pathogens and contaminants and the access site isexposed to the antiseptic material in the sponge 86.

It is desirable that during the rotation of the syringe barrel that theantiseptic cap assembly 80 does not rotate with respect to the housingand/or optionally that the plunger assembly 12 does not rotate withrespect to the syringe barrel 14 so that the threads 88 of theantiseptic cap can fully engage the threads of the access site. Thepresent invention provides a mechanism associated with the assembly 10for preventing the rotation of the antiseptic cap assembly 80 withrespect to the plunger assembly 12 and more preferably a mechanism oneither the plunger assembly or on the antiseptic cap 80 to preventrelative rotational movement between the antiseptic cap 80 and theplunger assembly 12. In an even more preferred form of the invention,the mechanism for preventing relative rotation of the antiseptic cap 80with respect to the plunger assembly 12 has mating portions on bothparts that when assembled cooperatively engage one another to preventrelative rotation. It is also contemplated that a separate mechanism,device or member could be used to lock the two parts together to achievethis purpose.

If a user of the assembly 10 grasps the assembly 10 by the antisepticcap and plunger assembly 12 then the interlocking structures between thepiston assembly 12 and the syringe barrel 14 would not necessarily beneeded. Accordingly, FIGS. 5, 9-11 show exemplary structures for lockingthe antiseptic cap assembly 80 inside the housing 60 so that these partsrotate together and one part does not rotate in a direction or at a ratedifferent from that of the other part. Further, FIGS. 15-18 showexemplary structures for interlocking the antiseptic cap plungerassembly 12 with the syringe barrel 14.

In one preferred form of the invention the housing 60 will have afeature or structure that forms an interference fit with an externalsurface of the antiseptic cap 80. Even more preferably, the internalsurface of the side wall 62 of the housing will have a feature orstructure to form an interference fit with a portion of the antisepticcap 80. In another preferred form of the invention the antiseptic capwill have a feature to form an interference fit with the housing 60 andeven more preferably the outer surface of the antiseptic cap 80 willhave a feature to contact the inner surface of the housing side wall 62.

In another preferred form of the invention the housing and the cap eachhave a feature or structure that cooperatively engage one another toprevent relative rotation of the cap 80 and the housing 60. FIG. 5 showsone preferred form of the invention having a plurality ofcircumferentially spaced and axially extending ribs 100 on the internalsurface 87 of the housing side wall (internal ribs 100) for engaging thewall 62 of the antiseptic cap to lock the cap in place to preventrotation of the cap when positioned inside the housing 60. In apreferred form of the invention, the internal ribs 100 extend from abottom wall 102 up to an intermediate height of the housing sidewall 62.In a preferred form of the invention the internal ribs 100 will have aheight roughly equal to a height of the cap 82. A plurality of internalslots 108 are defined between each set of adjacent internal ribs 100.The internal ribs 100, in a preferred form of the invention, will have awidth that tapers inwardly from proximate the bottom wall 102 to a top104 of the internal ribs so that the width of the internal ribs decreasefrom a bottom 106 of a rib to the top 104 of the rib. Also, it ispreferable that the top of the internal ribs have a generally arcuateprofile to act as a lead-in during insertion of the antiseptic cap intothe housing 60. Also, extending from the internal surface 87 of the cap82 is detent 109 positioned proximate a top portion of the side wall 62.

The antiseptic cap 82 has a plurality of circumferentially spaced andaxially extending ribs 120 extending along an external surface 122 ofthe cap 82 (external ribs 120) from an annular flange 123. The externalribs 120 are dimensioned for engaging a portion of the interior wall ofthe housing 62 to prevent relative rotation of the cap and the plungerassembly 12 and define a plurality of external slots one of each betweeneach adjacent pair of external ribs. When the cap 82 is positionedwithin the chamber 64 (FIGS. 9 and 11) each of the external ribs 120 arepositioned within an internal slot 108 and each of the internal ribs arepositioned within an external slot to lock together these parts toassure that the cap rotates in the same direction as the plunger rod.FIGS. 6 and 11 also show that when the cap 82 is positioned within thehousing 60, the detent 109 contacts the annular flange 123 to hold thecap in the housing to prevent or resist inadvertent dropping of the capfrom the housing prior to docking of the cap with the access site. Inone preferred form of the invention, the external ribs 120 arespecifically designed in conjunction with internal slots 108 so that theantiseptic cap is guided out of the storage chamber 64 as the cap isscrewed onto the threads of the access site.

FIGS. 12-14 show several embodiments of gripping surfaces on the housing60 to facilitate use of the assembly 10 or the plunger assembly 12. FIG.12 shows axially extending and circumferentially spaced protuberances130 on an outer surface of the wall 62. The protuberances 130 can havenumerous different cross-sectional shapes including circular, polygonal,oval and irregular and, in a preferred form of the invention, extendfrom the flange 70 to a bottom of the housing.

FIG. 13 shows a housing 60 that has no flange 70 and has protuberances130 on the wall 62 extending substantially the entire height of thehousing 60. FIG. 14 shows a housing 60 where the outer surface of thewall 62 is relatively smooth but has a series of circumferentiallyspaced and axially extending protuberances 130 on a circumferential edgeof the flange 70.

As with the cap and plunger assembly rotational locking features orstructures, the optional plunger assembly and syringe barrel lockingfeature or structure can be positioned alone on the plunger assembly 12,or alone on the syringe barrel or have cooperating structures on boththe plunger assembly 12 and the syringe barrel. It is also contemplatedthat a separate mechanism, device or member could be used to lock thetwo parts together to achieve this purpose.

FIGS. 15-18 show various embodiments for the optional feature of lockingthe plunger assembly 12 from rotational motion with respect to thesyringe barrel 14. In one embodiment shown in FIGS. 15-17 and 21 a wing150 extending axially along an outside surface of the housing side wall62 engages a tooth 152 positioned on an interior surface of the syringebarrel at is proximal end. More preferably, the plunger assembly 12 willhave more than one wing 150 with each wing being circumferentiallyspaced from the other. In an even more preferred form of the inventionthe plunger assembly will have four wings 150 spaced 90 degrees from oneanother. Also, in a more preferred form of the invention, the syringebarrel will have a plurality of circumferentially spaced teeth. When theplunger assembly is nearly fully inserted into the syringe barrel eachof the wings will extend into a tooth to prevent rotation of the plungerassembly 12 with respect to the syringe barrel 14.

FIG. 18 shows another embodiment of a locking feature to preventrotation of the plunger assembly 12 with respect to the syringe barrel14. In this embodiment an annular protuberance 160 positioned on aninterior surface of the syringe barrel at its proximal end engages anannular detent 162 on an outside surface of the plunger rod. Thiscaptures the plunger rod such that reflux is reduced.

FIGS. 19 and 20 show an antiseptic cap equipped plunger assembly andnon-refluxing syringe assembly 170. There are numerous methodologies forreducing reflux while utilizing the access site of a central venouscatheter. In this embodiment the flange 70 of the plunger assembly 12abuts the flange 24 of the syringe barrel prior to the piston 50contacts an interior surface of the syringe end wall 30.

It is contemplated that the antiseptic cap 80 of the present inventionneed not be coupled or combined with a plunger or a piston. FIGS. 22 a,b show an antiseptic cap 200 having three circumferentially spaced ribs120 for grasping by the hand of a user of the cap. FIG. 22 a shows thecap without a sponge and FIG. 22 b shows the cap with a sponge. The cap200 can be used for the same purposes of the cap 80 described above butwill be assembled to the catheter by hand. All other features of the cap200 are essentially the same as described above with the exception thatthe cap 200 does not have to be dimensioned to fit within a chambercarried by a syringe plunger. FIGS. 23 and 24 show varying frequency ofribs 120 and varying shapes and sizes.

FIG. 25 shows the cap 200 proximate the valve 39 and FIGS. 26 and 27show the cap 200 docked to the valve 39.

Suitable sponges of the present invention can include any spongesuitable for use for medical purposes and can be naturally occurring orsynthetic. The sponges can be die cut into suitable shapes or can bemolded into the desired shape. It is desirable that the sponge 86 beattached to the antiseptic cap to prevent the sponge from inadvertentlyfalling out of the cap. FIG. 28 shows the cap 200 is captured between anannular wall 202 and a disc 204 attached to the cap by any suitablemethod such as ultrasonic or vibrational welding or other techniqueswell known in the art. FIGS. 29 and 30 show a variation on the cap ofFIG. 28 and holds the sponge in place with a plastic sheet 206 heatwelded to the cap. In one preferred form of the invention the sponge isattached by an adhesive or by other method to form an assembly which isthen attached to the cap.

FIGS. 31 a, b show the cap 200 having a coaxially disposed and axiallyextending actuating post 220 circumferentially surrounded by a sponge 86having a centrally positioned hole to fit over the post 220. FIG. 31 ashows the cap 200 in initial engagement with the access site 39 and FIG.31 b shows the cap threaded onto the access site 39 and the actuatingpost opens the valve 39 an antiseptic fluid is allowed to flow into thevalve.

FIGS. 32-34 show varying shaped sponges that, in one preferred form ofthe invention, were molded into various desirable shapes. The sponge ofFIG. 34 has a central opening 230 to facilitate attaching the sponge tothe cap and to filling the sponge with antiseptic, anticoagulant orother suitable fluids set forth herein. FIG. 35 shows the cap having acentrally disposed energy director 231 an ultrasonic welder 232 beingbrought into cooperative engagement with the sponge on a side of thesponge opposite the energy director 231. By applying ultrasonic energythe energy director melts and attaches the sponge to the cap. FIG. 36shows a filling device 240, having a lumen 242 and a dispensing head 244in fluid communication with a source of antiseptic, anticoagulant or thelike for dispensing a metered amount of such fluid into the interiorportion of the sponge.

FIG. 37 shows an alternative embodiment of the antiseptic cap 200 wherethe sponge is replaced by an antiseptic coating on the actuating post220 and/or around the entire internal and/or external surface of thecap.

When the cap is not incorporated into the plunger assembly, manypackaging options exist. One such embodiment, FIG. 38, shows theantiseptic cap 200 positioned in a blister pack 230 prior to sealing theblister pack.

The syringe barrel and plunger can be fabricated from any materialsuitable for its purpose and includes glass and polymeric material.Suitable polymeric materials include, but are not limited to,homopolymers, copolymers and terpolymers formed from monomers such asolefins, cyclic olefins, amides, esters, and ethers. The polymericmaterial may be a blend of more than one polymeric material and can be amonolayer structure or a multilayer structure. In one preferred form ofthe invention the syringe barrel and the plunger are injection moldedfrom a polypropylene material.

The piston 50 can be formed from any suitable material including apolymeric material, natural or synthetic rubber or a silicone material.The stopper can be selected from a material with a desired durometer sothat reflux is reduced when the stopper engages an inner surface of thedistal end wall of the syringe barrel.

Suitable locking and flush solutions for filling inside the syringebarrel and/or for soaking the sponge 86 include a lower alcohol selectedfrom ethanol, propanol and butanol. The locking solution can be a singlelower alcohol or a blend of lower alcohols.

Suitable locking solutions can also include a lower alcohol with anantimicrobial and or an anticoagulant. Thus, the locking solution canhave a single component, two components or more than two components.Suitable locking solutions can contain at least one lower alcohol in arange from 1% to 99% by volume and at least one other anti-microbialand/or anti-coagulant compound in a range from 1% to 99% by volume. Thelower alcohol will usually be in aqueous solution, typically at 1% to99% by volume, usually from 5% to 95% by volume. The at least one otheranti-microbial is selected from the group consisting of taurolidine andtriclosan, and the at least one anti-coagulant is selected from thegroup consisting of riboflavin, sodium citrate, ethylene diaminetetraacetic acid, and citric acid.

In one preferred form of the invention, the syringe assembly 10 will bepre-filled with one of the locking solutions and will be packaged by amanufacture and shipped to a health care provider. A cannula or needlewill be attached to the distal end of the barrel and placed into fluidcommunication with the fluid access site of an indwelling central venouscatheter. The flush solution will be injected into the catheter to cleanor lock the catheter. Afterwards, the cap assembly 80 will be removedfrom the plunger 17 and the cap will be docked to the fluid access siteof the catheter.

From the foregoing, it will be observed that numerous variations andmodifications may be effected without departing from the spirit andscope of the invention. It is to be understood that no limitation withrespect to the specific apparatus illustrated herein is intended orshould be inferred. It is, of course, intended to cover by the appendedclaims all such modifications as fall within the scope of the claims.

1-20. (canceled)
 21. An antiseptic cap for use with an access sitecomprising: a housing having a generally cylindrical side wall defininga chamber having an open upper end and an end wall closing the oppositeend, the housing having a substantially flat outer bottom surface, thegenerally cylindrical side wall having a set of threads on an innersurface of the generally cylindrical side wall and on an externalsurface of the generally cylindrical side wall a plurality ofcircumferentially spaced ribs extend radially outward from and axiallyalong the generally cylindrical side wall; and an access site contactingsurface associated with the housing having an antiseptic substance forcontacting a distal surface of the access site.
 22. The cap of claim 21wherein the access site contacting surface is an absorbent materialpositioned within the chamber.
 23. The cap of claim 22 wherein theantiseptic substance is a liquid and the liquid is releasably retainedwithin the absorbent material.
 24. The cap of claim 20 wherein theantiseptic substance is a coating on a portion of the wall.
 25. The capof claim 24 further comprising an axially extending access post having aportion within the chamber and having an exterior surface coated withthe antiseptic material.
 26. An antiseptic cap for use with an accesssite comprising: a housing having a generally cylindrical side walldefining a chamber having an open upper end and an end wall closing theopposite end, the housing having a substantially flat outer bottomsurface, the generally cylindrical side wall extending from the bottomsurface to the open upper end, the generally cylindrical side wallhaving a set of threads on an inner surface of the generally cylindricalside wall extending from the open upper end, and on an external surfaceof the generally cylindrical side wall a plurality of circumferentiallyspaced ribs extend radially outward from and axially along the outermostperipheral surface of the generally cylindrical side wall at regularintervals about the entire cylindrical side wall; and an access sitecontacting surface associated with the housing having an antisepticsubstance for contacting a distal surface of the access site.
 27. Thecap of claim 26 wherein the access site contacting surface is anabsorbent material positioned within the chamber against the end wall.